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| ID | Type | Description | Link |
|---|---|---|---|
| S-20120129 | Other Identifier | Regional ethics committee | |
| 2012-002844-25 | EudraCT Number |
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| Name | Class |
|---|---|
| Region of Southern Denmark | OTHER |
| University of Southern Denmark | OTHER |
| Læge Fritz Karners og hustrus Foundation | UNKNOWN |
| Overlæge dr. med. Edgar Schnohr og hustru Gilberte Schnohrs Foundation |
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The purpose of this study was to test whether peroperative infiltration of the phrenic nerve during lung surgery would protect patients against postoperative shoulder pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Experimental | Phrenic nerve block with Ropivacaine |
|
| Placebo | Placebo Comparator | Phrenic nerve block with Sodium chloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phrenic nerve block with Ropivacaine | Drug |
|
| |
| Phrenic nerve block with saline |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder pain within 6 hours after the operation | Shoulder pain 6 hours after the operations. Number of patients and numeric rating scale score (0-10) | Retrospective numerical rating scale, 6 hours after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with shoulder pain during the first 3 postoperative days. | Postoperative days 0-3 | |
| NRS for shoulder pain during the first 3 postoperative days. | NRS=numerical rating scale score 0-10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morten R Blichfeldt-Eckhardt, MD | Departement of anaesthesia and intensive care, Odense University Hospital, Odense, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement of Anaesthesia and intensive care, Odense University Hospital | Odense | Region Syddanmark | 5000 | Denmark |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| UNKNOWN |
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| Drug |
|
|
| Postoperative days 0-3 |
| Opioid use during the first 3 postoperative days | Morphine equivalents | Postoperative day 0-3 |
| Time spent in the recovery room | Measured at discharge from the recovery room. Estimated to be on postoperative day 0 or 1. |
| Shoulder pain 3 months postoperatively | 3 months postoperatively |
| NRS for shoulder pain 3 months postoperatively | NRS=numerical rating scale 0-10 | 3 months postoperatively |
| Thoracic pain 3 months postoperatively | 3 months postoperatively |
| NRS for thoracic pain 3 months postoperatively | NRS=numerical rating scale 0-10 | 3 months postoperatively |
| opioid use 3 months postoperatively | 3 months postoperatively |
| Shoulder function 3 months postoperatively | Measured by DASH-score before the operation and after 3 months | 3 months postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |